In my opinion, the approval of Pembro-chemo for 1st line therapy of non-squam NSCLC, based on the small randomized Phase II KEYNOTE 021 trial, with no link to PD-L1 expression, was premature. The implications are so great that waiting a few months for the Phase III results is warranted. Afteral...

Results from the phase III KEYNOTE 189 had been recently reported and published. This follow-up study provided the confirmatory OS benefit signal that had been awaited regarding chemo+immunotherapy in nonsquamous NSCLC. Improvement in OS was seen across all PD-L1 categories. Key points to consider a...

I am concerned about the FDA approval of the Pembro-chemo combination based upon a 123 patient study with a primary endpoint of ORR.  I was taught that small randomized studies are good for prompting larger definitive studies that should answer the question.  Indeed, these studies are ongo...

Update: A new study has resulted in this clinical area – please follow the link here for more recent discussion. 

I consider the approval to be premature for the reasons already stated by Drs. Gandara and Otterson. Given the large population of patients involved I believe it is wise to await confirmatory data before applying this regimen to all (or even most) patients with newly diagnosed metastatic nonsqu...

I'm reasonably impressed with the data, the PFS of 13-14mo seems very promising, the median time to response is only 1.5months, it's irrespective of PD-L1 expression, though I think in subset analysis, PD-L1 overexpressors had a response rate of 80% with all cohorts, RR of about 52% or so. So, I wo...